Life Cycle Management, Staff Engineer

Job Description

About Johnson & Johnson

Johnson & Johnson is a global healthcare company that believes health is everything. Their mission is to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through their expertise in Innovative Medicine and MedTech, they aim to deliver breakthroughs in healthcare solutions, impacting health for humanity.

Job Description: Life Cycle Management, Staff Engineer

This position is for a Life Cycle Management Staff Engineer, located in Irving, TX. The role involves:

Key Responsibilities:

• Presenting business-related issues or opportunities to management.
• Complying with all federal, state, local, and company regulations, policies, and procedures.
• Identifying and mitigating risks and challenges associated with product life cycle activities.
• Executing product life cycle projects with mid/high level of complexity, interacting with R&D, Quality, and Regulatory teams for life cycle and design change projects for legacy product lines.
• Adhering to company guidelines related to Health, Safety and Environmental practices.
• Demonstrating independent understanding and application of core GMP fundamentals (Data Integrity, Good Manufacturing Practices, and Good Documentation Practices).
• Ensuring all product life cycle activities comply with regulatory requirements, industry standards, and company policies. Staying updated on regulatory changes.
• Identifying opportunities for process optimization, cost reduction, and quality improvement throughout the product life cycle. Implementing improvements and standardized methodologies for efficiency.

Qualifications:

Required:

• Bachelor’s degree in Engineering or Manufacturing Operations. Master’s degree in Engineering or MBA preferred.
• Minimum 4 years’ experience in Operations within New Product Development, Quality, and/or Manufacturing, Supply, and Logistics, with significant project and leadership skills.
• Experience in the Medical Device or Diagnostics industry.
• Ability to work effectively in a fast-paced, multifaceted environment and lead multiple projects simultaneously.
• Proven successful completion of developing and leading technical and/or business challenges. Demonstrated ability to interact and lead cross-functional/multi-disciplined teams.
• Proven knowledge of risk management principles and their application to labeling, including hazard identification, risk assessment, risk control measures, and risk communication strategies.
• Ability to interpret and apply labeling requirements for medical devices, including content, format, language, symbols, and placement. Familiarity with labeling standards.
• Familiarity with regulatory requirements and standards relevant to product life cycle management.
• Proficiency with MS Office and Statistical Analysis Software.
• Demonstrated track record of Project Management.
• Ability to prioritize multiple commitments and technical problem-solving duties.
• Ability to shift priorities according to department/facility needs and be open to different ideas/approaches.
• Advanced proficiency in written and verbal communication.

Preferred:

• Experience in a New Product Development project.
• Understanding of the healthcare-supervised industry Quality Systems and Change Control procedures.
• Six Sigma/Process Excellence and/or Design Excellence experience.

Other:

• Fully on-site 5 days a week in Irving, TX.
• Travel up to 10% international or domestic.

This is an equal opportunity employer and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.